Hinged tissue support device

ABSTRACT

A tissue support device is provided for managing access through tissue. The tissue support device engages the tissue proximate an opening in the tissue and biases the tissue support device to bring the engaged tissue together.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/035,939 entitled, “Hinged Tissue Support Device”, filed Feb. 26,2011, which is incorporated herein by reference in its entirety.

BACKGROUND

1. The Field of the Invention

Embodiments of the invention relate generally to medical devices. Moreparticularly, embodiments of the invention relate to medical devices formanaging access in body tissue including closing large holes in the bodytissue.

2. The Relevant Technology

Catheterization and interventional procedures, such as angioplasty orstenting, are generally performed by inserting a hollow needle through apatient's skin and tissue into the patient's vascular system. A guidewire may be advanced through the needle and into the patient's bloodvessel accessed by the needle. The needle is then removed leaving theguide wire in place, enabling an introducer sheath to be advanced overthe guide wire into the vessel.

A catheter or other device may then be advanced through a lumen of theintroducer sheath and over the guide wire into a position for performinga medical procedure. As the various devices are introduced through theintroducer sheath, the opening or access site formed in the vessel maybe subjected to additional trauma or tearing during the medicalprocedure.

Upon completing the procedure, the devices and introducer sheath areremoved from the opening, leaving a puncture site or opening in thevessel wall. Traditionally, external pressure would be applied to thepuncture site until clotting and wound sealing occur; however, thepatient must remain bedridden for a substantial period after clotting toensure closure of the wound. This procedure, however, may be timeconsuming and expensive, requiring as much as an hour of a physician'sor nurse's time. It is also uncomfortable for the patient and requiresthat the patient remain immobilized in the operating room, catheter lab,or holding area. In addition, the insertion and removal of variousmedical devices can lead to problems such as enlarging or tearing thepuncture, which can make it more difficult to close the opening.

BRIEF SUMMARY

Embodiments of the invention relate to a tissue support device. Thetissue support device engages tissue proximate an opening in the tissue.The tissue support device is biased such that the tissue engaged by thetissue support device can be brought in proximity for closing.

In one example, the tissue support device manages access to an openingin tissue. The tissue support device includes first and second portionshaving corresponding engagement mechanisms. The engagement mechanismsare configured to engage the tissue proximate the opening. A biasingmechanism connects the first and second portions and biases the firstand second portions to a closed position.

In another example, the tissue support device is configured to assist inclosing an opening in tissue and/or manage access to a body lumenthrough the opening. The tissue support device includes first and secondportions. Each of the first and second portions have a central regionsextending between ends of the portions. An engagement mechanism extendslaterally from each of the portions. The tissue support device alsoincludes a biasing mechanism that joins the portions together. Thebiasing mechanism exerts a force to bias the portions to a closedposition.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the invention. Thefeatures and advantages of the invention may be realized and obtained bymeans of the instruments and combinations particularly pointed out inthe appended claims. These and other features of the present inventionwill become more fully apparent from the following description andappended claims, or may be learned by the practice of the invention asset forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which at least some of the advantagesand features of the invention can be obtained, a more particulardescription of the invention briefly described above will be rendered byreference to specific embodiments thereof, which are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be considered tobe limiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 is a perspective view of a vessel and illustrates an opening inthe vessel as well as a large opening in the vessel;

FIG. 2 illustrates a side view of a tissue support device for closing anopening in the vessel or for assisting in closing the opening;

FIG. 3 illustrates an example of a device configured for opening atissue support device;

FIG. 4A shows an illustrative example of a tissue support device;

FIG. 4B shows an example of an engagement mechanism enabling the tissuesupport device to aid in closing the vessel;

FIG. 4C shows another example of the engagement mechanism;

FIG. 4D shows another example of the engagement mechanism; and

FIG. 5 shows an illustrative example of a biasing mechanism included ina tissue support device.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In general, embodiments of the invention relate to methods and devicesfor managing access to body lumens, for example by providing tissuesupport. Although various embodiments of the invention may be discussedwith reference to a vessel, one of skill in the art can appreciate, withthe benefit of the present disclosure, that embodiments of the inventioncan also be used in conjunction with other tissue, lumens, and/or withother procedures. Embodiments of the invention relate to a tissuesupport device for closing or managing holes including large holes intissue. More specifically, embodiments of the invention relate to atissue support device that manages access to tissue and that aids inclosing openings formed to access the tissue.

In many medical procedures, it is often necessary to create an openingor an access site in tissue for various reasons, including to introducemedical devices into the tissue or into body lumens. For example, anopening (e.g., an arteriotomy) is often formed in a vessel during astenting procedure. After the opening is formed in the vessel, othermedical devices are often introduced into the vessel lumen through thesame opening. These medical devices are often larger than the needlethat originally formed the opening. As a result, the opening is likelyto be enlarged in order to accommodate those medical devices. In otherwords, the insertion, use, and/or removal of these medical devices maycause additional trauma to the vessel (e.g., tearing of the vessel).

The opening in the vessel may also be due to trauma unrelated to amedical procedure, for example a wound or an accident. The size of theopening in the tissue may be relatively larger than, for example, anarteriotomy.

Embodiments of the invention relate to a tissue support device that maybe placed around or proximate the opening formed in the vessel duringthese types of procedures or occurrences. The tissue support device maybe configured to reduce or minimize trauma to the vessel as well as aidin closing the opening regardless of how the opening is formed (e.g.,surgery, accident, wound, etc.). Embodiments of the invention arefurther configured for aiding in the closure of large holes, forexample, when the vessel is almost completely open, or for bringing thewalls of the vessel together such that the opening can be closed using aclip or sutures.

Embodiments of the invention may reduce or minimize tearing that mayoccur at the opening during the insertion, use, and/or removal ofmedical devices such as an introducer sheath or catheter or for otherreasons. Minimizing or reducing trauma to the vessel, by way of exampleonly, can improve recovery time, keep the size of the opening to aminimum, and/or make the procedure easier to perform.

Generally, the tissue support device is placed and/or anchored at aprocedure site. The tissue support device, for example, may be placed inthe tissue proximate the opening in the tissue. The tissue supportdevice may be anchored at different locations around the opening.Anchoring the tissue support device in the tissue proximate the openingenables the tissue support device to control the size of the opening.When the tissue support device closes, for instance, the edges of thevessel defining the opening are brought closer together. Closure of theopening can then be completed, by way of example only, using otherdevices such as clips or sutures. Embodiments of the invention cantherefore aid in closing openings formed in a vessel. The completion ofthe closure process may be achieved using other devices such as clips orsutures.

The tissue support device typically engages at least some of the tissuesurrounding or proximate the opening in the tissue. Often, the tissuesupport device engages the tissue in various locations proximate theopening.

In order to close the opening and/or perform a procedure through theopening in the tissue, the tissue support device is configured to openand close. The tissue support device typically includes a biasingmechanism that urges the tissue support device to a closed position.While the tissue support device can be held in an open position (forexample by the insertion of an apparatus through the tissue supportdevice), the biasing mechanism closes the tissue support device when theapparatus is removed.

When a medical device needs to be introduced through the opening in thevessel, the tissue support device can be opened to allow entry of themedical device. Thus, the medical device is inserted through both theinterior of the tissue support device and the opening in the tissue inorder to be introduced into the body lumen. Often, the medical deviceitself operates to open the tissue support device to permit entry of themedical device into the opening in the vessel. Although the biasingmechanism biases the tissue support device to a closed position, thetissue support device does not typically interfere with the insertion,removal, and/or use of the medical device. The tissue support device mayremain engaged with the tissue during the use of a medical device.

When the medical device is removed, the tissue support device may returnto a closed position. In some examples, closing of the tissue supportdevice may at least partially close the opening in the vessel. Thetissue support device, in this sense, can therefore provide tissuesupport and provide preclosure support as well.

The tissue support device includes engagement mechanisms that can engagethe vessel wall (or other tissue) proximate the opening. The engagementmechanisms attach the tissue support device to the vessel wall. Theengagement mechanisms, for instance, may pierce or at least partiallypierce the tissue proximate the opening to anchor the tissue supportdevice to the tissue. The engagement mechanisms remain attached to thetissue (or vessel wall) during opening and/or closing of the tissuesupport device.

When a medical device (e.g., an introducer sheath or catheter) needs tobe introduced, the tissue support device is opened to enableintroduction of the medical device via the opening through the tissuesupport device. When the medical device is withdrawn from the opening,the biasing mechanism of the tissue support device returns the tissuesupport device to its original position, closing or at least partiallyclosing the opening in the vessel in some examples. In some instances,closure of the tissue support device brings the edges of the vesseldefining the opening in proximity such that another device (e.g., a clipor sutures) can be used to complete the closure procedure.

FIG. 1 shows an example of a vessel 100. The vessel 100 shows openings104 and 106. The opening 104 is an example of an opening (e.g., anarteriotomy) formed during a medical procedure and provides an accesssite for the medical procedure. The opening 106 is comparatively largerthan the opening 104 and may also have been formed during a procedure,although the opening 106 may also be the result of a wound or accident.

Embodiments of the tissue support device disclosed herein can be usedwith large holes, such as the opening 106, as well as smaller holes,such as the opening 104. In this example, walls 108 are examples oftissue proximate the opening 104 and walls 110 are examples of tissueproximate the hole opening.

FIG. 2 illustrates a side view of a tissue support device 200 forclosing an opening in the vessel or for aiding in closing the opening inthe vessel. The tissue support device 200 can provide tissue support,for example during a medical procedure.

The tissue support device 200 is positioned on the vessel 100 proximatethe opening 106. The tissue support device 200 is configured to open andclose and is typically biased towards a closed position.

The tissue support device 200 includes a portion 202, a portion 204 thatare connected or joined by a biasing mechanism 206. The biasingmechanism 206 may be integral to either or both of the portions 202 and204. Alternatively, the biasing mechanism 206 may be a separatecomponent that is connected with the portions 202 and 204. The biasingmechanism 206 enables each of the portions 202 and 204 to rotate aboutan axis defined by the biasing mechanism 206 in one example. Typically,the tissue support device includes a pair of biasing mechanisms. Theportions 202 and 204 are joined at the respective ends by the biasingmechanisms.

The portion 202 includes an engagement mechanism 210 and the portion 204includes an engagement mechanism 208. The engagement mechanisms 208 and210 can be configured to engage with the walls of the vessel 100 orother tissue. The engagement mechanisms 208 and 210 may engage withtissue that is proximate the opening 106. As a result, the tissuesupport device 200 can bring the edges of the opening 106 togetherduring closure of the opening.

In the closed position, the portions 202 and 204 have substantially thesame shape and may be in contact along their length or slightlyseparated in the closed position. Alternatively, the portions 202 and204 may be shaped such that the portions 202 and 204 are only in contactin specific locations in the closed position.

The engagement mechanisms 208 and 210 may be integral with the portions202 and 204. In addition, the engagement mechanisms 208 and 210 mayextend from the portions 202 and 204 in order to engage with the tissue.The engagement mechanisms 202 and 204 can vary in terms of dimensionsand configurations.

During deployment of the tissue support device 200, in one example, thetissue support device 200 is deployed in the closed position. The tissuesupport device 200 is then opened. The tissue support device 200 canopen, for example, as the portions 202 and 204 rotate about an axisdefined by the biasing mechanism 206. The tissue support device 200 canopen, by way of example at least 180 degrees or more if necessary toengage the tissue.

Opening the tissue support device 200 causes the engagement mechanisms208 and 210 to engage the tissue proximate the opening 106. Once theengagement mechanisms 208 and 210 engage the tissue, the tissue supportdevice 200 brings the edges of the opening 106 together upon closing.

FIG. 3 illustrates an example of a device configured for opening thetissue support device 200. In FIG. 3, a device 300 is inserted betweenthe portions 202 and 204 to open the tissue support device 200. By wayof example only, the device 300 may be an introducer sheath, a catheter,a needle, or other device. In one example, the device may have an end302 that forms an edge or blade. The end 302 of the device may beconfigured to be inserted between the portions 202 and 204. As the end302 is inserted further into the tissue support device 200, the device300 may be configured to expand or open the tissue support device 200.In one example, the device 300 may be rotated to further open the tissuesupport device 200 and separate the portions 202 and 204 such that theengagement mechanisms 208 and 210 engage the walls of the vessel 100around the opening 106. More specifically, the device 300 may be rotated(e.g, approximately 90 degrees) to open the tissue support device 200and separate the portions 202 and 204. The end 302 of the device 300 maybe configured like a blade that is thin in a first direction andcomparatively thick in another direction.

Opening the engagement mechanisms 208 and 210 may cause the engagementmechanisms 208 and 210 to engage or attach to the walls of the vessel100. Once the tissue support device 200 is engaged with the vessel 100,the portions 202 and 204 (and the engagement mechanisms 208 and 210)bring the walls defining the opening in the vessel closer together whenthe tissue support device 200 closes.

In one example, the device 300 may include an introducer sheath, aneedle, a catheter, or the like. In addition, the device 300 can be usedto hold the tissue support device 200 open while a procedure isperformed through the tissue support device 200 and the opening 106. Forexample, the device 300 may be an introducer sheath and other medicaldevices can be introduced into the vessel's lumen through the introducersheath. In another example, the various devices used to perform aprocedure can each be inserted individually. In this case, the variousdevices can each be used to open the tissue support device 200 asnecessary.

To facilitate opening the tissue support device 200, at least theportions 202 and 204 or a part thereof may be coated to reduce frictionbetween the portions 202 and 204 and the various medical devices usedduring the medical procedure.

The biasing mechanism 206 of the tissue support device 200 closes or atleast partially closes the opening 106 each time a device is withdrawn.This may help reduce, for instance, blood loss.

FIG. 4A shows an illustrative example of a tissue support device 400,which is an example of the tissue support device 200. The tissue supportdevice 400 includes portions 402 and 404 that are joined by a biasingmechanism 406. In one example, the portions 402 and 404 and theengagement mechanism 406 may be a single integrated unit. Alternatively,the portions 402 and 404 may be joined by the biasing mechanism 406.Alternatively, one of the portions 402 and 404 may be integrally formedwith the biasing mechanism 406.

FIG. 4A further illustrates that the portion 404 includes a centralregion 436 extending between an end 432 and an end 434. The end 432 isconnected to or joins the biasing mechanism 406 while the end isconnected to or joins the biasing mechanism 438. The portion 402 issimilarly configured and includes ends 440 and 442 that are connected toor join with the biasing mechanisms 406 and 438, respectively. In thisexample, the portion 402 may be similarly configured like the portion404.

The ends 432 and 434 and the central region 438 of the portion 404 havea generally arcuate shape. In other words, the portions 404 curves in aplane that includes the biasing mechanisms 406 and 438. In anotherexample, the portion 404 may have a convex shape such that the portion404 curves in at least two dimensions. When the portions 402 and 404have a planar arcuate shape, the portions 402 and 404 may be in contactwhen the tissue support device 400 is in the closed position. When theportions 402 and 404 have a multidimensional curve, the portions 402 and404 may not be in contact in the closed position.

FIG. 4A also illustrates engagement mechanisms 408 and 410, which areexamples of the engagement mechanisms 208 and 210. The engagementmechanisms 408 and 410 includes needles 424. The needles 424 extend froma side 418 of the portion 402. Alternatively, the needles 410 may extendfrom a top 420 or bottom 426 of the portion 402.

In this example, the needles 424 are shaped to extend from the portion402 and narrow to a point 422. The points 422 of the needles 424 canpierce (partially or completely) the walls of the vessel around theopening. The needles 424 can each be configured in a similar manner orin different manners. For instance, some of the needles may be shorter,thicker, have a different orientation, or the like or any combinationthereof. More generally, the dimensions and/or orientations of theindividual needles 424 can vary or be the same.

FIGS. 4B, 4C, and 4D illustrate examples of different configurations ofthe needles 424. FIG. 4B illustrates a needle 412 that curves inwardlyas the needle extends from the portion 402. FIG. 4C illustrates needles414 that extend out from the portion 402 substantially straight withlittle curve. FIG. 4D illustrates needles 416 that includes barbs 418.The barbs 418 on at least some of the needles 416 are typicallyconfigured to ensure that the needles 416 do not disengage from thevessel 100 after engaging with the vessel 100. The barbs 418 can beincluded on any of the various needles disclosed herein.

FIG. 5A illustrates an example of a biasing mechanism 506 in a tissuesupport device 500, which is an example of the tissue support device200. The biasing mechanism 506 includes an end 508 and an end 510. Theend 508 and the end 510 are joined at a pivot 512 that enables the ends508 and 510 to rotate relative to each other. As the tissue supportdevice 500 opens, the ends 508 rotate about the pivot 512. In anotherexample, the pivot 512 may correspond to a portion of the tissue supportdevice 500 that flexes when the portions 502 and 504 are separated. Asthe pivot 512 flexes, the pivot 512 exerts a force to bias the tissuesupport device to the closed position.

In this example, the ends 508 and 510 are at least partially hollow. Aspring 514 is disposed inside of the ends 508 and 510 and arranged topass through the pivot 512. The ends 508 and 510 typically include astop disposed in their interiors against which the ends of the spring514 rest. As the tissue support device opens, the stops (or moregenerally the portions 502 and 504) push against the ends of the spring514. As the tissue support device 500 opens, the spring 514 exerts aforce that biases the tissue support device 500 to the closed position.The spring 514 is typically strong enough to close the tissue supportdevice 500 after the tissue support device 500 is engaged with thetissue.

In another example, the bias mechanism 506 includes a hinge and theportions 502 and 504 open and close about the hinge.

In another example, the bias mechanism 506 may include a shape memorymaterial. In this case, the tissue support device 500 can be deformedwhen opening or when inserting a medical device. The bias mechanismreturns to a set shape, for example, when the medical device is removed.

In one embodiment, the portions 502 and 504 may be relativelyinflexible. In this example, the relative movement of the portions 502and 504 is accomplished through the bias mechanism.

The tissue support device 500 is configured to close large holes, forexample, when the vessel is almost completely open. The tissue supportdevice 500 can be opened at least 180 degrees such that the tissuesupport device is relatively flat. This enables the tissue supportdevice 500 to be used with large holes.

In one embodiment, the tissue support device can include a variety ofsuitable deformable alloy metal materials, including stainless steel,silver, platinum, tantalum, palladium, cobalt-chromium alloys or otherknown biocompatible alloy metal materials.

In one embodiment, the tissue support device may also include shapememory materials.

In one embodiment, the tissue support device can include a suitablebiocompatible polymer in addition to or in place of a suitable metal.The tissue support device can include biodegradable or bioabsorbablematerials, which may or may not be elastically deformable.

It is further contemplated that the external surface and/or internalsurface of the tissue support device or tissue support device element(e.g., exterior and/or luminal surfaces) can be coated with anothermaterial having a composition different from a primary tissue supportdevice material. The use of a different material to coat the surfacescan be beneficial for imparting additional properties to the tissuesupport device, such as providing radiopaque characteristics,drug-reservoirs, and improved biocompatibility.

In one configuration, the external and/or internal surfaces of thetissue support device can be coated with a biocompatible polymericmaterial as described herein. Such coatings can include hydrogels,hydrophilic and/or hydrophobic compounds, and polypeptides, proteins oramino acids or the like. Specific examples can include polyethyleneglycols, polyvinylpyrrolidone (PVP), polyvinylalcohol (PVA), parylene,heparin, phosphorylcholine, polytetrafluorethylene (PTFE), or the like.

Accordingly, the coating material can contain a drug or beneficial agentto improve the use of the tissue support device. Such drugs orbeneficial agents can include antibiotics, for example.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A tissue support device for managing access to anopening in tissue, the tissue support device comprising: a first portionhaving a first engagement mechanism configured to engage the tissueproximate the opening; a second portion having a second engagementmechanism configured to engage the tissue proximate the opening; abiasing mechanism connecting the first portion and the second portion,wherein the biasing mechanism biases the first portion and the secondportion towards a closed position.
 2. The tissue support device of claim1, wherein the first portion and the second portion are configured tomove between the closed position and an open position by rotating aboutan axis defined by the biasing mechanism.
 3. The tissue support deviceof claim 1, wherein the biasing mechanism enables the first portion andsecond portion to open at least 180 degrees.
 4. The tissue supportdevice of claim 1, wherein the first portion and the second portion arehave a concave shape.
 5. The tissue support device of claim 1, whereinthe biasing mechanism includes: a first biasing mechanism connected afirst end of the first portion with a first end of the second portion;and a second biasing mechanism connecting a second end of the firstportion with a second end of the second portion.
 6. The tissue supportdevice of claim 1, wherein the biasing mechanism includes a first hingeand a second hinge, wherein the first hinge and the second hinge jointhe first and second portions.
 7. The tissue support device of claim 1,wherein the biasing mechanism comprises at least one spring, wherein thespring is positioned inside of the biasing mechanism.
 8. The tissuesupport device of claim 1, wherein the first engagement mechanism andthe second engagement mechanism each comprise a plurality of needlesextending from the first portion and the second portion.
 9. The tissuesupport device of claim 8, wherein at least some of the needles comprisebarbs are angled to facilitate insertion of the plurality of needlesinto the tissue while resisting removal of the one or more needles fromthe tissue.
 10. The tissue support device of claim 8, wherein theplurality of needles curve inwardly toward the opening when engaged withthe tissue.
 11. A tissue support device for assisting in closing anopening in tissue, the tissue support device comprising: a first portionhaving a first central region extending between a first end and a secondend, the first portion having a first engagement mechanism extendinglaterally from the first portion; a second portion having a secondcentral region extending between a first end, a second end, the secondportion having a second engagement mechanism extending laterally fromthe second portion in a direction substantially opposed to the firstengagement mechanism when the first portion and the second portion arein a closed position; a biasing mechanism joining the first end of thefirst portion with the first end of the second portion and joining thesecond end of the first portion with the second end of the secondportion, wherein the biasing mechanism exerts a force to bias the firstportion and the second portion to the closed position.
 12. The tissuesupport device of claim 11, wherein the first central region and thesecond central region are have a concave shape.
 13. The tissue supportdevice of claim 11, wherein the biasing mechanism comprises a firsthinge and a second hinge, the first hinge joining the first end of thefirst portion with the first end of the second portion and the secondhinge joining the second end of the first portion with the second end ofthe second portion.
 14. The tissue support device of claim 11, whereinthe first engagement mechanism extends from one of a side, a top, or abottom of the first portion and wherein the second engagement mechanismextends from one of a side, a top, or a bottom of the second portion.15. The tissue support device of claim 14, wherein the first engagementmechanism and the second engagement mechanism each comprise at least oneneedle, the at least one needle configured to engage the tissueproximate the opening when the first portion and the second portion arein an open position, wherein the first portion and the second portionbring the tissue proximate the opening closer together in the closedposition.
 16. The tissue support device of claim 15, wherein the atleast one needle curves inwardly toward the opening in the tissue. 17.The tissue support device of claim 11, wherein the first portion and thesecond portion are integrated with the biasing mechanism.
 18. The tissuesupport device as recited in claim 11, wherein the biasing mechanismcomprises a plurality of hinges, each hinge including a spring.